24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population

A Prospective, Open Label Study to Assess the 24-hour IOP Pattern Recorded With SENSIMED Triggerfish® in a Healthy Population

A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on healthy volunteers and patients with glaucoma. However, healthy subjects were much younger than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database was almost twice higher than the number of healthy subjects. As it is generally accepted that intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore, improving our knowledge of the "healthy" 24-hour IOP pattern in comparison to glaucoma profiles would be beneficial for management of glaucoma.

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Device: Sensimed Triggerfish

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medical Center
  • Naharya, Israel
    • The Western Galilee Hospital in Naharya
  • Petach Tikva, Israel
    • Rabin Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject of Caucasian origin
• Healthy subject without previous ocular disease
• Aged between 40 and 80 years, of either sex
• Not more than 6 diopters spherical equivalent in the study eye
• Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

• Corneal or conjunctival abnormality precluding contact lens adaptation
• Previous refractive surgery
• Occludable or closed iridocorneal angle
• Sleep apnea syndrome
• Subjects with allergy to corneal anesthetic
• Subjects with contraindications for silicone contact lens wear
• Subjects not able to understand the character and individual consequences of the investigation
• Participation in other clinical research within the last 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device; Portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.	Device: Sensimed Triggerfish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The 24-hour IOP pattern recorded with Sensimed Triggerfish (TF) in healthy subjects, aged between 40 and 80 years Secondary	24-hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Diurnal and nocturnal IOP patterns in healthy subjects	24 hours
Assessment of corneal biomechanical properties in healthy population (if available)	24 hours
Relationship between the 24-hour IOP pattern monitored by TF and the 24-hour blood pressure pattern in healthy subjects (if available)	24 hours
Assessment of Safety and tolerability through adverse events	6 months

Collaborators and Investigators

• Sponsor: Sensimed AG
• Investigators: Principal Investigator: moshe lusky, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 20, 2013
• First Posted (ESTIMATE): July 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2014
• Last Update Submitted That Met QC Criteria: August 25, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: TF-1217